Clinical Trial

Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day

Recruiting
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Record status
This record was last updated October 30, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
SAFE HV is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (LAAO) device implant procedures in a single calendar day.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-05-28; most recent amendment 2025-10-29.
Trial Details
NCT Number NCT06436924
Lead Sponsor Heart Rhythm Clinical and Research Solutions, LLC
Collaborators: Boston Scientific Corporation
Conditions Atrial Fibrillation
Enrollment 678 participants
Start Date 2024-05-14
Primary Completion 2025-12-30 (estimated)
Study Completion 2026-03-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-30